MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. GOMCO CLAMP 1.3CM; CLAMP, CIRCUMCISION

Model Number DYND04131

Device Problem Material Fragmentation (1261)

Patient Problem Insufficient Information (4580)

Event Date 03/22/2023

Event Type  Injury  

Event Description

During a circumcision, the gomco was noted to have silver shavings that fell on to the sterile drape after the procedure was completed, but prior to being taken off of the infant.It appears that it is part of the silver coating of the instrument that is flaking off.

• Brand Name: GOMCO CLAMP 1.3CM
• Type of Device: CLAMP, CIRCUMCISION
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; one medline place; mundelein place IL 60060
• MDR Report Key: 16642788
• MDR Text Key: 312305202
• Report Number: 16642788
• Device Sequence Number: 1
• Product Code: HFX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 03/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: DYND04131
• Device Catalogue Number: DYND04131
• Device Lot Number: 2023021090
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/23/2023
• Event Location: Hospital
• Date Report to Manufacturer: 03/30/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/30/2023
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Sex: Male